Optical disc assemblies for performing assays

ABSTRACT

This invention relates to an optical disc assembly capable of receiving an insert upon which an analyte of interest may be disposed. The optical disc assembly can be read by an optical disc reader, such as by a standard CD or DVD reader, and the analyte disposed on the insert can be detected by the optical disc reader. The optical disc assembly may have one or more data layer in which operational information or assay information is encoded. Hologram may be used to encode operational information or assay information.

This application claims priority from U.S. Provisional Application Ser.No. 60/254,394, filed Dec. 8, 2000; U.S. Provisional Application Ser.No. 60/255,233, filed Dec. 12, 2000; U.S. Provisional Application Ser.No. 60/293,917, filed May 24, 2001; U.S. Provisional Application Ser.No. 60/294,051, filed May 29, 2001; U.S. Provisional Application Ser.No. 60/294,052, filed May 29, 2001; U.S. Provisional Application Ser.No. 60/303,437, filed Jul. 6, 2001; U.S. Provisional Application Ser.No. 60/306,226, filed Jul. 18, 2001; and U.S. Provisional ApplicationSer. No. 60/323,405, filed Sep. 19, 2001.

FIELD OF INVENTION

The present invention relates to optical discs and their use to performassays. More particularly, this invention relates to optical discs andmethods for using the optical discs to discriminably obtain signalsgenerated by investigational features, including analyte-specific signalelements, that are disposed upon surfaces of optical disc inserts.

BACKGROUND OF THE INVENTION

Optical discs have been used to detect microscopic samples. Theadvantages of using optical discs for detection and characterization ofmicroscopic structures are discussed in WO 96/09548 (Gordon) andcommonly assigned U.S. application Ser. No. 09/421,870 (Worthington),the disclosures of which are incorporated herein by reference in theirentirety. However, consumers may be reluctant to use optical discsbecause microscope slides, rather than optical discs, are theconventional choice for performing assays.

Therefore, there exists a need to make an optical disc assembly that isadapted to accommodate microscope slides or the like. Nonoperationalfeatures or investigational features and structures can be disposed onthe microscope slides. A standard optical disc reader may be used toboth track the optical disc assembly and acquire investigational signalsgenerated by the investigational features.

SUMMARY OF THE INVENTION

Therefore, it is an object of the present invention to provide anoptical disc assembly capable of receiving an insert upon which ananalyte of interest may be disposed. The optical disc assembly can beread by an optical disc reader, and the analyte disposed on the insertcan be detected by the optical disc reader.

In accordance with one aspect of the present invention, the optical discassembly includes (1) a first layer containing optically readablestructures which are trackable by an optical disc reader and which haveencoded speed information enabling the optical disc reader to rotate theoptical disc assembly at a speed that is determinable from the speedinformation; and (2) at least one insert having a surface capable ofreceiving an analyte which can be detected by the optical disc reader.The optical disc reader may be a CD reader or a DVD reader.

In one embodiment, one surface of the first layer is impressed with theoptically readable structures which are coated with a reflective layer.The insert may be laser-proximal to the first layer and capable offocusing the reading beam of the optical disc reader on the reflectivelayer. The analyte-bearing surface of the insert may face the firstlayer. The insert may also be laser-distal to the first layer, and thereflective layer is a semi-reflective layer which may have areflectivity of between 18 and 30%.

In another embodiment, the optical disc assembly includes a secondlayer, and the insert and the reflective layer are located between thefirst layer and the second layer. The second layer may be locatedlaser-proximal to the first layer and the insert, and function like alens to focus the reading beam of the optical disc reader on thereflective layer. The analyte-bearing surface of the insert may faceeither the first layer or the second layer.

In yet another embodiment, the insert is replaceable, and contains glassor plastic.

In a preferred embodiment, the optical disc assembly includes at leastone counterweight insert to balance the disc assembly against theanalyte-bearing insert.

In another preferred embodiment, the optical disc assembly is a dualdata layer disc, which includes two data layers. Each of the two datalayers has a surface impressed with optically readable structures whichmay have encoded operational information or assay information and whichmay be coated with a reflective or semi-reflective layer. Theanalyte-bearing surface of the insert may face either of the two datalayers. One of the two data layers may function as a lens to focus thereading beam of the optical disc reader on the optically readablestructures contained in either of the two layers.

In accordance with another aspect of this invention, the insert is atleast partially embedded in the operational layer of the disc assembly.The disc assembly may include another layer, functioning as a lens, tofocus the reading beam on the operational structures.

In accordance with yet another aspect of this invention, the opticaldisc assembly includes a hologram containing optically readablestructures which have encoded tracking information and speed informationenabling the optical disc reader to rotate the optical disc assembly ata speed that is determinable from the speed information. This embodimentof the present invention further includes at least one insert having asurface capable of receiving an analyte which can be detected by theoptical disc reader. The optical disc reader preferably is a CD readeror a DVD reader. The optical disc assembly may include a lens layercapable of focusing the reading beam of the optical disc reader on animage plane of the hologram. The analyte-bearing surface of the insertmay be within or adjacent to the image plane of the hologram. The insertmay be located between the hologram and a second layer in the opticaldisc assembly. One surface of the second layer may be impressed withoptically readable structures which may have encoded operationalinformation or assay information and which may be coated with areflective or semi-reflective layer. The hologram may also have encodedassay information.

In one embodiment, the optical disc assembly includes the analyte whichis disposed on the insert. The analyte may be a biological, chemical, orbiochemical analyte. The analyte may be adjacent to the operationalstructures or other optically readable structures in the optical discassembly. When a hologram is used, the analyte may be adjacent to theimage plane of the hologram. Preferably, at least part of the analyte iswithin the image plane of the hologram.

In accordance with another aspect of this invention, the analyte held bythe insert in the optical disc assembly is detected using a CD or DVDreader. The detection includes the steps of: (1) introducing the opticaldisc assembly into a CD or DVD reader; (2) reading the optically discassembly; and (3) obtaining a signal which is indicative of the presenceof the analyte.

In accordance with yet another aspect of this invention, a kit isprovided for detecting an analyte. The kit includes a disc including afirst layer that contains optically readable structures which haveencoded tracking information and speed information enabling an opticaldisc reader to rotate the disc at a speed that is determinable from thespeed information. The kit according to this aspect of the presentinvention further includes an insert having a surface capable ofreceiving the analyte. This insert is capable of being coupled to thedisc to enable the optical disc reader to detect the analyte held by theinsert.

BRIEF DESCRIPTION OF THE DRAWINGS

All the drawings used herein are given by way of illustration, notlimitation.

FIG. 1 shows a typical optical pickup used by an optical disc reader.

FIG. 2 shows a side cross-sectional view of a CD-type disc.

FIG. 3 illustrates a perspective view of the operational surface of aCD-R disc.

FIG. 4 depicts the position of three reading beams, as used by a typicalthree-beam pickup, relative to the tracks on the operational surface ofan optical disc.

FIG. 5 is an exemplary optical disc detector used by a three-beamoptical pickup.

FIG. 6 shows an illustrative block diagram of a chip set used by aCD-type optical disc reader.

FIG. 7 shows an illustrative block diagram of a chip set used by aDVD-type optical disc reader.

FIG. 8 depicts investigational structures applied to the air-incident,laser-proximal surface of a typical single layer CD-type optical disc.

FIG. 9 demonstrates an inverted CD-type single layer optical disc, withlaser incident from below.

FIG. 10 illustrates an inverted optical disc impressed with reverseimage wobble grooves.

FIG. 11 depicts an optical disc assembly including an insert associatedwith analytes.

FIG. 12 is a side cross sectional view of an optical disc assemblyincluding an insert and a nonintegral laser-proximal, laser-refractivecover.

FIG. 13 shows another optical disc assembly including a reflectivehologram which has encoded operational features, wherein the encodedoperational features appear to be located in the image plane of thehologram, and wherein analytes may be positioned within or adjacent tothe image plane.

FIG. 14 is a top perspective view of a polycarbonate laser-refractingcover.

FIG. 15 shows a side cross-sectional view of a dual layer DVD-type disc.

FIG. 16 is an exploded side perspective view of a dual data layeroptical disc assembly.

FIG. 17 depicts a side cross-sectional view of another dual data layeroptical disc assembly including internal channels.

FIG. 18 shows a side cross-sectional view of yet another dual data layeroptical disc assembly including assay-facilitating features.

FIG. 19 illustrates a side cross-sectional view of another dual datalayer optical disc assembly according to one embodiment of the presentinvention.

FIG. 20 shows a dual data layer optical disc assembly, wherein one ofthe data layers is a hologram.

FIG. 21 presents illustrative shapes of suitable inserts in accordancewith the present invention.

FIG. 22 depicts multiple ring-shaped inserts according to the presentinvention which can provide multiple sessions on a single disc.

FIG. 23 shows an arrangement of differently shaped inserts on an opticaldisc assembly implemented in accordance with the present invention.

FIG. 24 is an illustrative example for using a counterweight insertaccording to this invention.

FIG. 25 demonstrates an annular counterweight channel according to oneembodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

As used herein, “operational structures” or “operational features” in anoptical disc assembly refer to optically readable structures which areimpressed or encoded in the optical disc assembly and which enable anoptical disc reader to track, synchronize, or perform other customizedoperational functions. Operational structures may act as phasecomponents or provide interference patterns. Operational structures mayhave encoded speed information that enables the optical disc reader torotate the disc assembly at a speed determinable from the speedinformation. For instance, frame synchronization words or wobble groovesmay be used to provide speed information. Light returned from or passedover operational structures can be acquired by the optical disc readerto generate operational signals. These operational signals are used bythe optical disc reader to track, focus, synchronize, or perform otheroperational functions.

Operational structures may be imprinted or impressed in a surface of alayer in the disc assembly. Such a layer is referred to as an“operational layer,” and such a surface is referred to as an“operational surface.” In a typical CD disc, the operational layer isthe polycarbonate disc, and the operational surface is the laser-distalsurface of the polycarbonate disc. An optical disc assembly may havemore than one operational layer or operational surface. Preferredoperational structures include, but are not limited to, wobble grooves,pits and lands, dye marks, or any combination thereof

According to the present invention, operational structures may beadvantageously encoded in a hologram. Light returned from or transmittedthrough the hologram can create an image plane within which the encodedoperational structures appear to be positioned. The encoded operationalstructures, as appeared in the image plane of the hologram, preferablyare in the form of wobble grooves, tracks of pits and lands, or anyother type of operational structures that may be physically impressed inan optical disc's operational layer.

Operational structures, impressed or encoded, may be in a variety offormats. Suitable formats for this invention include, but are notlimited to, CD formats, DVD formats, any combination thereof, or otheroptical disc formats. CD formats include, but are not limited to,CD-ROM, CD-R, and CD-RW formats. DVD formats include, but are notlimited to, DVD-R, DVD-RW, and DVD-RAM formats. As appreciated by thoseof skill in the art, other CD or DVD formats or other optical discformats, including those that have been or will be developed in thefuture, may be used in the present invention.

As used herein, an “investigational feature” or an “investigationalstructure” refers to any feature or structure which is placed ordisposed on or within an optical disc assembly to be examined. When readby an optical disc reader, an investigational feature or structure maybe capable of producing a signal which is not required for the opticaldisc reader to operate the disc assembly. Investigational features orstructures include analytes or analyte-specific signal elements. An“analyte-specific signal element” refers to any structure that may beused to signal the presence of a specific analyte that is disposed in anoptical disc assembly. Analyte-specific signal elements include boththose structures that are alone detectable by an optical disc reader andthose that require additional components before becoming detectable.

In accordance with one aspect of this invention, the optical discassembly is designed based on modification of standard optical discs.The optical disc assembly is read by an optical disc reader, which mayuse the optical pickup of a conventional optical disc reader, or anoptical pickup modified therefrom. The optical disc reader may be a CDreader or a DVD reader. As used herein, CD readers include, but are notlimited to, CD-ROM readers, CD Recordable (CD-R) readers, CD-Rewriteable(CD-RW) readers, or any reader capable of reading CD-format discs.Industry standard CD readers may be used in the present invention. Apreferred CD reader for this invention is a CD-RW reader or amodification thereof. As used herein, DVD readers include, but are notlimited to, DVD-R readers, DVD-RAM readers, DVD-RW readers, or anyreader that can read DVD-format discs. Industry standard DVD readers maybe used. As appreciated by one of skill in the art, other CD readers,DVD readers or optical disc readers, including those that have been orwill be developed in the future, may be used in the present invention.

Features of a conventional optical disc reader and an optical disc aredescribed in FIGS. 1, 2, and 3. FIG. 1 depicts a conventional reader'soptical pickup 810 which directs at least one reading beam to a CD-typeoptical disc 811. The path of the reading beam is indicated by thedashed lines. FIG. 2 provides an enlarged side cross-sectional view ofdisc 811. With reference to FIGS. 1 and 2, the optical pickup 810includes laser source 819, lenses 812, 813, and 814, beam splitter 815,quarter wave plate 820, and detector 818. Light source 819, typically alaser diode, emits a light beam which passes through beam splitter 815and then is collimated by lens 812. Objective lens 813 focuses the laserbeam onto a reflective layer in optical disc 811.

The laser beam can be reflected from the reflective layer and returnedthrough objective lens 813 and quarter wave plate 820 to beam splitter815. Quarter wave plate 820 changes the polarization of the laser beamso that beam splitter 815 can direct the reflected laser beam throughlens 814, which may focus the reflected laser beam onto detector 818.Astigmatic element 816, which may be a cylindrical lens, may be includedbetween beam splitter 815 and detector 818 to introduce astigmatism inthe reflected laser beam.

As shown in greater detail in FIG. 2, the CD-type disc 811 includesthree layers. From laser-proximal to laser-distal, these three layersare transparent substrate 112, reflective layer 114, and protectivelayer 116. As used herein, a layer in an optical disc assembly refers toa thickness of material. For instance, a layer may be a substrate discor a coating of reflective material. A layer may also be an insert whichcan be assembled into another layer in the disc assembly. A layer may beflat or not flat. A layer may be homogeneous or non-homogenous. Thedepth of a layer may be uniform or not uniform. A layer may be anassembly of several parts.

The total depth of disc 811 is about 1.2 mm. The senior standard forcompact discs, republished as IEC (International ElectrotechnicalCommission) 908, colloquially the “Red Book,” permits a CD-type disc tohave a physical thickness of between 1.1 and 1.5 mm. Discs with otherthickness can also be used in this invention.

Although the disc shown in FIG. 2 includes three physical layers, thereis only a single data layer. Such a disc is thus referred to as a singledata-layer (or “single layer”) disc. Such a disc may also be describedas a “CD-type” disc. CD discs, including CD-ROM, CD-R, and CD-RW discs,are examples of CD-type discs. In comparison, a DVD disc includes twodata layers, and therefore is referred to as a dual data layer,“multiple layer”, or “dual layer” disc. DVD discs include DVD-R, DVD-RW,and DVD-RAM disc.

Transparent substrate 112 makes up most of the 1.2 mm thickness of atypical CD-type disc, as measured along the optical axis. Transparentsubstrate 112 also provides both optical and structural featuresnecessary for disc operation.

With respect to the optical features, the refractive properties oftransparent substrate 112 serve to focus the incident laser light onreflective layer 114. On the most laser-proximal surface of a CD-typedisc, the laser spot has a diameter of approximately 800 μm. Transparentsubstrate 112 further focuses the beam, achieving a diameter ofapproximately 1.7 μm at reflective layer 114. In design and manufactureof optical discs, the thickness and index of refraction of transparentsubstrate 112 are selected to achieve this focusing function.

Transparent substrate 112 also provides the principal structuralintegrity of the disc. Reflective layer 114 is approximately 0.05 to0.10 microns in thickness, and protective layer 116 typically includes alacquer material that hardens when exposed to ultraviolet light, and hasa thickness between 10 and 30 microns. Thus, transparent substrate 112makes up the major layer, and is the only layer capable of impartingsufficient rigidity to the disc.

Substrate layer 112 is typically impressed with a spiral track thatstarts at the innermost readable portion of the disc and then spiralsout to the outermost readable portion of the disc. In a non-recordabledisc, this track is made up of a series of embossed pits, each having adepth of approximately 1/4 of the wavelength of the light used to readthe disc. The pits have varying lengths. The length and spacing of thepits encode data. As further discussed below, the spiral wobble grooveof a recordable disc contains a dye rather than pits. As used herein, aspiral wobble groove can be considered as a series of wobble groovesconnected consecutively to form a spiral track. Two portions of such aspiral wobble groove 118 are shown in a perspective view in FIG. 3.Reference numeral 110 denotes the land of the wobble groove.

Transparent substrate 112 is typically manufactured by an injectionmolding process, in which molten polycarbonate is injected into a moldcavity having a “stamper.” The stamper has a reverse image of spiralgroove 118, and is made from a master by electroforming. The injectionmolding process typically takes 5 to 10 seconds per disc.

Reflective layer 114 is approximately 0.05 to 0.10 microns in thickness,and typically contains a reflective metallic material, such as aluminum,silver, gold, or copper. For the CD-R format, a reflection coefficientof approximately 65 percent is recommended in the official formatspecification, but few discs actually meet this level. Most drives havegain control circuitry, and are capable of reading discs having a muchlower reflection coefficient. When the disc is being read, reflectivelayer 114 reflects the laser beam back to the sensors in the discreader.

Reflective layer 114 may be prepared using a magnetron sputteringprocess, in which a solid target is bombarded with ions, releasing metalmolecules that are used to form reflective layer 114. The vapordeposition process is slow, and is generally only used for masteringdiscs. A chemical wet “silvering” process (using silver, nickel, orother metal) may also be used to form reflective layer 114 ontransparent substrate 112.

Protective layer 116 typically contains a lacquer material that hardenswhen exposed to ultraviolet light, a process called “curing.” Protectivelayer 116 has a thickness between 10 and 30 microns. Protective layer116 serves to protect reflective layer 114 from scratches and oxidation,and provides a convenient surface on which a label may be printed.Protective layer 116 is typically applied to transparent substrate 112and reflective layer 114 through a spin-coating process, whereby a smallamount of a material that hardens when exposed to ultraviolet light issprayed on the disc near the inner diameter of reflective layer 114, andthe disc then is spun at high speed, causing a thin layer of thematerial to cover the surface of the disc. The disc is subsequentlyexposed to ultraviolet light, causing the material to harden.

The various CD and DVD standards contemplate discs having a nominaldepth (in the dimension defined by the optical axis) of 1.2 mm and anominal diameter in the radial dimension of 120 mm. The senior standardfor compact disc technology (colloquially, the “Red Book”) permitsphysical thickness of between 1.1 and 1.5 mm (for all layers combined).Disc readers are capable of accommodating some additional variance, anddiscs suitable for CD and DVD drives may have a depth maximally of about2.4 mm and minimally of about 0.8 mm, preferably from 1.0 to 1.4 mm,more preferably from 1.1 to 1.3 mm, and most preferably 1.2 mm. Withrespect to the nominal 120 mm diameter, disc readers may accommodatediscs of radial diameter from about 100 to 140 mm, preferably from about110 to 130 mm, more preferably from 115 to 125 mm, and most preferably120 mm.

In addition, the standard allows discs with radial diameter of 8 cm (80mm). The dimensions of the mounting and clamping rings remain the sameas those for 120 mm discs, and only the outer diameter is reduced,therefore reducing the data area of the disc. Commercially available CDand DVD readers and reader/writers accommodate discs of this diameter intheir disc trays. A disc of this diameter presents certain advantages inthe practice of the present invention, among which are a commensuratereduction in assay sample volume required to effect contact with theentire disc surface, as well as the ability to package such a disc in asleeve dimensioned identically to the sleeve of a 3 ½ inches magneticfloppy disc.

Furthermore, various additional standards, such as those defining amagneto-optical “minidisc” or analog laser disc have been, or will be,developed. Thus, a disc of the present invention may have a radialdiameter as small as 50 mm and as large as that for a standard laserdisc, and may be adapted to such size standards as will be developed inthe future. One skilled in the art will appreciate that the term “disc”contemplates any suitably rotatable media, whether or not perfectlycircular, whether or not flat.

Referring now to FIG. 5, exemplary detector 81 and its associatedelectronics are described. Detector 818 typically includes a centralquad detector flanked by two additional detector elements. The centralquad detector is split into four sensor elements a, b, c, and d. Each ofsensor elements a, b, c, d, e, and f provides an electrical signalindicative of the intensity of the reflected laser beam striking thatelement.

A CD reader can use a three-beam pickup, wherein the light beam is splitinto three beams consisting of a main beam and two tracking beams. Themain beam is focused onto the operational surface of an optical disc andis centered on a track. The tracking beams fall on either side of thetrack. For example, as shown in FIG. 4, main beam 821 is centered ontrack 824 as defined by pits 822. The two tracking beams 823 fall oneither side of track 824. By design, the three beams are reflected fromthe optical disc and directed to detector 818 such that main beam 821falls on the central quad detector, and the two tracking beams 823 fallon sensor elements e and f. The sum of the electrical signals generatedby the central quad detector (a+b+c+d), is a radio frequency (RF)signal, also referred to as a high frequency (HF) or quad-sum signal.The circuitry in FIG. 5 is just one example of circuitry that issuitable for providing focusing and tracking error signals to an opticaldisc player.

The RF signal, obtained from summing the signals from all of sensorelements a, b, c, and d, may be used to extract data recorded in theoptical disc. Typically, the process is performed by analog circuitry incombination with one or more integrated circuit chips. Often, thecircuitry may take the form of a special chip set.

FIGS. 6 and 7 are illustrative block diagrams of exemplary chip sets fora typical CD drive and DVD drive, respectively.

Numerous designs and configurations of optical pickups and associatedelectronics that may be suitable for the present invention are describedin Compact Disc Technology, by Nakajima and Ogawa, IOS Press, Inc.(1992); The Compact Disc Handbook, by Pohlmann, A-R Editions, Inc.(1992); Digital Audio and Compact Disc Technology, by Baert et al.(eds.), Books Britain (1995); and CD-Rom Professional's CD-RecordableHandbook: The Complete Guide to Practical Desktop CD, Starrett et al.(eds.), ISBN:0910965188 (1996), all of which are incorporated herein intheir entirety by reference.

FIG. 6 includes buffer amplifiers 826, 827, and 828. These amplifiersenable external circuitry, such as oscilloscopes and analog to digitalconverters, to be connected to the various signals generated by theoptical disc drive without interfering with normal drive operation. Formore information about reading and processing signals, such as thoseproduced by investigational features or structures, see U.S. patentapplication Ser. No. 90/______, entitled “Disc Drive System and Methodsfor Use with Bio-disc” filed Nov. 9, 2001; U.S. Provisional ApplicationSer. No. 60/270,095, entitled “Signal Processing Apparatus and Methodsfor Obtaining Signal Signatures of Investigational Features Detected ona Surface of an Optical Disc Assembly” filed Feb. 20, 2001; and U.S.Provisional Application Ser. No. 60/292,108, entitled “Signal ProcessingApparatus and Methods for Obtaining Signal Signatures of InvestigationalFeatures Detected on a Surface of an Optical Disc Assembly” filed May18, 2001, all of which are incorporated herein by reference.

As a general principle, in order for an optical disc reader to properlyoperate an optical disc, the optical disc reader is typically requiredto be able to (1) accurately focus above the operational surface of theoptical disc, (2) accurately follow the spiral track or utilize someform of uniform radial movement across the optical disc surface, and (3)recover enough information to facilitate a form of speed control.

As discussed above in conjunction with FIG. 2, transparent substratelayer 112 of the optical disc can focus the reader's laser upon thereflective layer 114. Failure to maintain correct thickness,transparency, and refractive index of transparent substrate layer 112may render the optical disc unreadable.

As shown in FIG. 2, operational structures are impressed in thelaser-distal surface of the substrate layer 112 and coated withreflective layer 114. Operational structures must be read in order tomaintain correct tracking. In a standard pressed CD, the disc readertracks a pitted spiral track that is impressed in a surface of thesubstrate layer. In a recordable CD, the disc reader tracks a spiralgroove that is also impressed in the substrate layer. The spiral groovemay be filled with dye.

FIG. 8 demonstrates a typical CD-type disc 811′ which is associated withanalytes 40 and 40′. Analytes 40 and 40′ are applied to theair-incident, the most laser-proximal surface of the disc 811′, and arelaser-proximal to the focal point of the incident laser. Analytes sodisposed would be undetectable by standard means. For instance, theanalytes would have to be in the range of the beam size at the incidentsurface, which may be about 800 μm, in order to be detectable by thelaser source. If so large, the analytes may, by virtue of theirinterposition between the laser and the reflective surface 114′,interfere with the reading of the operational structures embossed insubstrate layer 112′.

Thus, in order to adapt standard optical disc technology for detectionof analyte-specific structures or signal elements, there is a need todesign an optical disc having geometries and tracking schemes thatovercome the above problems. Illustrative suitable disc geometries andtracking schemes are described, for example, in WO 00/26677, entitled“Trackable Optical Discs with Concurrently Readable Analyte Material”which is incorporated herein by reference herein in its entirety. Theoptical disc assembly of the present invention may be used in accordancewith such geometries and schemes.

Disc inserts of the present invention may be used in conjunction with anumber of different types of discs, such as single data layer discs. Thephysical orientation of a standard, single data-layer disc, such as a CDor a CD-type disc, may effectively be inverted, presenting what wouldotherwise be the most laser-distal surface as the most laser-proximalsurface of the disc. To compensate for the inverted physicalorientation, an inverted image of the disc's operational structures maybe used.

FIG. 9 shows physical inversion of the disc 811 of FIG. 2. Light isincident from below. Protective layer 116 a now becomes the mostlaser-proximal layer in the disc 811 a. Reflective layer 114 a islaser-distal to protective layer 116 a, and transparent substrate 112 abecomes the most laser-distal layer in the disc 811 a.

From the perspective of the optical pickup of the reader, physicalinversion of an optical disc which has an operational surface impressedwith a spiral wobble groove effectively converts each original land onthe operational surface to a groove, and each original groove to a land.Inversion may also effect changes in the non-symmetric features in theoperational surface, such as the direction of the spiral of the wobblegroove. To restore the proper orientation of data after physicalinversion of the disc, and in particular to restore the properorientation of operational structures, a reverse image wobble groove maybe used to provide operational structures in an inverted disc. FIG. 10shows an example of an inverted disc with a reverse image wobble groove.The reverse image wobble groove may be impressed into substrate 112 busing a conventional mother stamper, as opposed to a son stamper that istypically used to make a conventional wobble groove disc. More detailsabout making an optical disc impressed with a reverse image wobblegroove can be found in WO 00/26677, entitled “Trackable Optical Discswith Concurrently Readable Analyte Material” which is incorporatedherein by reference. Physical inversion of an optical disc including atrack of pits and lands may also be used in the present invention. Insuch a case, the original pits become bumps on the operational surface.

FIG. 11 shows a single data layer disc that has its protective layerremoved. Insert 500 has been attached, such as glued, to the reflectivelayer of disc 130. Analytes or analyte-specific signal elements 136 havebeen disposed upon insert 500. Like other figures, FIG. 11 is not drawnto scale. If the insert is thick enough, analytes 136 preferably arepositioned between insert 500 and substrate 132. The operationalstructures in the disc may be a wobble groove or a track of pits andlands.

In this type of assay disc, the analytes or analyte-specific signalelements may be located substantially confocal with or adjacent to thetracking or other operational features embossed in the laser-proximalsurface of substrate 132. This geometry greatly simplifies the problemof achieving and maintaining focus concurrently on the disc'soperational features and the analytes or analyte-specific signalelements.

It will be understood that the analyte-specific signal elements and theoperational structures, particularly those having encoded tracking andsynchronization information, need not be in the identical focal plane.It suffices that the signal elements and operational structures aresufficiently confocal or adjacent to each other. As used herein, anobject is adjacent to a structure if the object and the structure areclose enough so as to permit a disc reader's optical head to detect themboth. An object is adjacent to a trackable surface or layer if theobject is closed enough to the trackable surface or layer such that anoptical disc reader can both detect the object and track the surface orlayer. Likewise, an analyte-bearing surface is adjacent to a trackablesurface or layer if an optical disc reader can both detect the analytesdisposed on the analyte-bearing surface and track the trackable surfaceor layer. An object is substantially confocal with a structure orsurface if the object and the structure or surface are within a focaldepth of the reading beam of the optical disc reader. The focal depth ofthe reading beam may be about 2 micrometers.

As shown in FIG. 11, the reflective layer is now laser-distal to insert500. There is no transparent substrate layer present to assist the laserto focus on the reflective layer, as shown in FIG. 2. One solution is toadd an extra focus correction lens to the disc reader's optical pickup.

Alternatively, or in addition thereto, the distance between the opticalpickup and the disc's most laser-proximal surface can be adjusted sothat the laser focuses on the reflective layer of the disc. If desired,however, insert 500 may be formed of sufficient thickness and frommaterials whose refractive properties are well known in order to focusthe light beam correctly on the disc's operational structures. In oneembodiment, the analyte-bearing surface of insert 500 faces thereflective layer, while insert 500 serves as a lens to focus the readinglaser beam. In another embodiment, the disc uses one or more inserts ofsufficient size and geometry to cover all or substantially all of thereflective layer of disc 130.

In yet another embodiment, a laser-refracting member is used as the mostlaser-proximal layer in the disc assembly. The cover serves to refract,and thus is capable of focusing the incident reading beam on the insertor the disc's reflective layer. Suitably designed, the cover alone or incombination with inserts may obviate alteration in the reader's optics.Inserts can be at least partially inserted into or otherwise attached tothe cover if desired. As used herein, a layer in an optical disc iscapable of focusing a reading beam of an optical disc reader upon anobject if the reading beam, which is directed to the object while theoptical disc reader is operating the optical disc, can pass through thelayer and become focused on the object. Preferably, the refractive indexof the layer is significantly greater than the refractive index of air,as appreciated by those of skill in the art. For instance, in a typicalCD-recordable (CD-R) disc, the transparent substrate is capable offocusing the reading beam on the operational structures. The substrateis composed principally of polycarbonate, and has a refractive index ofbetween 1.55 and 1.58. Other layer or layers may also exist in theoptical path of the reading beam to help the reading beam become focusedon the object.

In a preferred embodiment, the disc assembly in FIG. 11 can be read by adisc reader in such a manner that substrate 132 is laser-proximal toinsert 500. A second reflective layer may exist, and is positionedlaser-distal to insert 500. In this configuration, substrate 132functions as a lens and may focus the reading beam upon analytes 136.Preferably, the operational structures of the disc are impressed in thelaser-distal surface of substrate 132 and are coated with asemi-reflective layer. Because the low reflectivity (for instance, about18 to 30%) of the semi-reflective layer, a CD-R or DVD reader maypreferably be used in this embodiment.

FIG. 12 shows a disc 630 associated with a non-integral cover 640. Disc630 includes disc substrate 632 and reflective layer 634. Wobble groove638 (or a track of pits and lands) is impressed in substrate 632 andcoated by reflective layer 634. Insert 502 can be partially insertedinto the cover 640. Analyte-specific signal elements 636 are disposed oninsert 502. Another example of a suitable cover is cover 640′, as shownin a top perspective view in FIG. 14. In one embodiment, the disc isconfigured such that the analyte can be disposed between reflectivelayer 634 and insert 502.

Preferably, the disc 630 may be read in such a manner that substrate 632is laser-proximal to insert 502 and the signal elements 636. A secondreflective layer may exist, and is positioned laser-distal to insert 502and the signal elements 636. The reflective layer 634 preferably issemi-reflective, and has a low reflectivity such as from about 18 to30%. The disc reader may be, but is not limited to, a CD-R reader or aDVD reader.

In a preferred embodiment, the disc assembly (which includes disc 630,the insets, and the cover) is dimensioned to approximate the standardsize of a unitary optical disc, that is, 1.2 mm in depth and either 80mm or 120 mm in diameter. However, it is also contemplated that the sizeof the disc assembly may vary substantially therefrom. The disc assemblymay still be capable of meeting the necessary optical and mechanicalrequirements in order for a standard disc reader to read the discassembly. For instance, the light beam of the standard disc reader maybe able to correctly focus on the disc's operational plane. The discassembly may clamp properly onto the spindle of the disc reader. Theweight of the disc assembly may not vary substantially from the standardweight because otherwise the reader's motor might not be able tomaintain a proper rotational speed.

The laser refracting disc cover can be in the form of a nonintegral oran integral cover, hingeably or otherwise moveably or modifiablyattached. In the nonintegral embodiment, the disc cover and substratemay be assembled and disassembled by use of machine-type threads,detents, or other mechanical means and provided in a kit includinganalyte and counterweight inserts. Nonintegral covers may be reversibly(e.g. removably) or irreversibly attachable to the other part of thedisc assembly.

Cover 640 and insert 502 may include polycarbonate to take advantage ofits well known optical qualities and the ready availability of devicesadapted to its molding. In addition, other types of plastics may beused, such as polymethyl acrylic, polyethylene, polypropylene,polyacrylate, polymethyl methacrylate, polyvinylchloride,polytetrafluoro-ethylene, polystyrene, polycarbonate, polyacetal,polysulfone, celluloseacetate, cellulose-nitrate, nitrocellulose, ormixtures thereof Glass can be used as well.

As noted above, analyte-specific signal elements are preferably disposedsubstantially confocally with the operational structures in a singledata layer disc assembly. This permits the reading beam to focussubstantially confocally on the analyte-specific signal elements and theoperational structures. When signal elements fall into the operationalstructures, for instance into a wobble groove, the confocal effect isoptimized.

Analyte-specific signal elements preferably are placed on insert 500,rather than on an external surface of the optical disc assembly. Whenthe analyte-specific signal elements are disposed on a plastic insert,for example, the number of potential chemistries that can be used toaffix the signal elements to the insert increases. For example, althoughgold-sulfur bonds prove widely adaptable, plastic presents a far widerselection of available attachment chemistries. Also, although a goldsurface can be patterned to present discrete sites for signal elementattachment, a plastic surface can be more readily derivatized to presentchemically reactive groups in spatially defined patterns, whichfacilitate the attachment of analyte-specific signal elements inspatially addressable patterns. Some of these patterns, and theiradvantages, are described in WO 00/05582, entitled “Optical Disc-BasedAssay Devices and Methods” and commonly assigned U.S. patent applicationSer. No. 09/120,049, filed Jul. 21, 1998, entitled “Optical Disc-BasedAssay Devices and Methods” both of which are incorporated herein byreference.

Another advantage of disposing analyte-specific signal elements on aninsert is that the disc assembly or the cover may be reused.

Polystyrene is useful in the construction of inserts or covers becausemany current clinical assays are conducted on polystyrene surfaces.Standard microtiter plates or dishes, used in enzyme-linkedimmunosorbent assays (ELISA) and radioimmunoassay (RIA), are made ofpolystyrene. Also, a wealth of experience attends the conduct ofclinical assays on polystyrene surfaces, and such assays may thusreadily be adapted to the present invention. Additionally, precisionmolding of polystyrene is well known.

The thickness of the cover, the insert, or both, can be adjusted toaccount for differences in the refractive index of the chosen plastic inorder to focus the light beam correctly.

In accordance with another aspect of this invention, a hologram is usedto provide operational signals. FIG. 13 shows an illustrative singledata layer disc 190, in which operational structures are encoded in areflective hologram 194, rather than physically impressed in discsubstrate 192.

Disc 190 includes disc substrate 192, hologram 194, and transparentprotective coating 198. Hologram 194 is a reflective hologram havingencoded operational structures required by the disc reader to operatethe disc. In operation, when a laser is reflected from hologram 194, itwill appear as though the operational structures, such as a wobblegroove with the correct orientation or a track of pits and lands, arepresent at hologram image plane 195.

Hologram image plane 195 may be laser-proximal to the hologram physicalplane 194 and substantially confocal with analyte-specific signalelements 646 disposed on insert 504. In operation, the laser is focusedon the plane 195 which is shared by both the analyte-specific signalelements and the encoded operational structures, such as the image of awobble groove encoded in the hologram. This configuration permits, ifdesired, concurrent and discriminable acquisition of operational data(e.g., tracking data) and analyte-specific data.

The light beam of the disc reader may be focused on the image plane ofthe hologram. This necessitates that the light beam would be lesstightly focused on the hologram's physical plane. Yet the very nature ofholographic imaging not only tolerates such “error” but benefitstherefrom. For example, each portion of a hologram's physical surfacemay generate the entirety of the image that is interferometricallyencoded thereon. As the illuminated portion decreases in size, however,the resolution degrades. Conversely, the larger the portion of thehologram illuminated, the better the image. Thus, the larger theilluminating laser spot on the hologram's physical plane, the better theimage of the disc's operational structures (e.g. a wobble groove).

Furthermore, although shown as integral to disc 190, hologram 194 may beremovable. This permits hologram 194 to be mass-produced using existinghigh-speed holographic printing processes. Furthermore, depending on theapplication, hologram 194 may be reversibly attachable to disc substrate192, potentially permitting reuse of substrate 192. These featurespermit low cost mass-production of disc assemblies readable by a widerange of optical readers.

As in the embodiments in which the operational structures are embossedand reflectively coated, a holographic optical disc assembly may includea laser-proximal, nonintegral cover that assists the laser to focus. Thefocal plane of the reading beam can be made substantially confocal withthe hologram image plane.

Disc substrate 192 in FIG. 13 and disc substrate 632 in FIG. 12 need notmeet the optical requirements of standard transparent disc substrate,such as substrate 112 in FIG. 2. This is because disc substrates 192 and632 are located laser-distal to the embossed operational structures orthe hologram.

In accordance with yet another aspect of this invention, a multiple datalayer disc may be used. The multiple layer disc may have the features asspecified in the Digital Versatile Disc (DVD) format.

FIG. 15 shows a side cross-sectional view of a typical dual layer DVDformat disc. Disc 280 includes laser-proximal substrate 282,semi-reflective layer 284, spacer layer 286, reflective layer 288, andlaser-distal substrate 290.

Proximal substrate 282, also referred to as layer 0, contains atransparent optical material, such as polycarbonate, having an index ofrefraction chosen to assist in focusing the reading beam onto either oneof the two reflective layers. Proximal substrate 282 may be manufacturedby an injection molding process similar to the process described abovefor manufacturing CD-Recordable format discs. Proximal substrate 282 istypically embossed with data at its laser-distal surface.

The data-bearing surface of proximal substrate 282 is coated with thesemi-reflective layer 284. The semi-reflective layer 284 includes a verythin coating of a material such as silicon, gold, aluminum, silver, orcopper that reflects some light and transmits some light. Thesemi-reflective layer 284 typically has a reflectivity of approximately18%, although a range of reflectivities can be accommodated. Forinstance, the semi-reflective layer 284 may have a reflectivity fromapproximately 18 to 30%. When a dual data layer disc is used, a DVDreader or CD-RW reader preferably is used. DVD or CD-RW reader hassuitable gain control circuitry for detecting and processing signalsreflected from a semi-reflective layer having a low reflectivity.

Distal substrate 290, also referred to as layer 1, includes a material,such as polycarbonate, that can be molded with a spiral data track atits laser-proximal surface. Since the reading beam usually will not passthrough distal substrate 290, its optical characteristics areunimportant. Distal substrate 290 can be manufactured by an injectionmolding process.

Distal substrate 290 is embossed with data in a spiral data track thatmay run parallel with the spiral data track in layer 0, for example,from the inner portion of the disc to the outer portion, or run in theopposite direction of the spiral data track in layer 0, for example,from the outer portion of the disc to the inner portion.

The data-bearing surface of distal substrate 290 is coated withreflective layer 288, which may include a thin layer of a reflectivematerial, such as gold, aluminum, silver, or copper. Reflective layer288 typically has a reflectivity that is designed to obviatereadjustment of gain control when the disc reader switches its readingfrom one layer to the other. A readjustment in gain control mayadversely affect tracking. Layer 1 in a dual layer disc often has areflectivity lower than 70%.

Spacer layer 286 provides 40 to 70 microns of space between layer 0 andlayer 1 of the two layer disc, and serves to bind proximal substrate 282to distal substrate 290. Spacer layer 286 can be, for example, anoptical adhesive having an index of refraction that is close to theindex of refraction of the material from which proximal substrate 282 ismanufactured.

In use, a DVD reader can focus the reading beam either on thesemi-reflective layer 284 to read data encoded in layer 0, or on thereflective layer 288 to read data encoded in layer 1. The multiple layernature of DVD discs and the concomitant dual-focus of DVD readers makeDVD well-suited for use in the present invention. For instance, theplane occupied by the operational features of the disc may be segregatedphysically from the plane occupied by analyte-specific elements,facilitating discriminable acquisition of both types of data.

Investigational structures, such as analyte-specific signal elements,may be placed on an insert. The insert may be constructed so that theinvestigational structures can be substantially confocal with oradjacent to the laser-distal surface of data layer 0, while the disc'stracking and other operational structures are positioned in data layer1. In another embodiment, the sample-bearing surface of the insert issubstantially confocal with or adjacent to the laser-proximal surface oflayer 1, whereas the disc's tracking and other operational structuresare located in layer 0.

FIG. 16 presents an exploded side perspective view of a multi-insertDVD-type dual data layer disc assembly. Disc assembly 300 includes twoportions: main portion 302 and cover portion 303. These portions may bepermanently affixed to one another, or may be separate but assemblable.Preferably, the main portion 302 and cover portion 303 are reversiblyassemblable. Inserts 506, 507, 508, and 509 are inserted into orotherwise attached to cover portion 303. Cover portion 303 is assembledover outer assay area 306 of main portion 302. Opening 308 and area 304can be dimensioned so as to permit a snug and reliable coupling betweenthe main portion and the cover portion.

Analogously to the single data layer embodiments described above, outerassay area 306 can be embossed with a wobble groove, or othersubstantially radial plane tracking features, to provide trackinginformation to an optical disc reader. Pursuant to DVD standards, thewobble groove can be either a forward image groove or a reverse imagegroove. A zoned constant linear velocity (ZCLV) format can be used.

Main portion 302 includes inner data area 304. Inner data area 304 isformatted in a manner similar to a normal dual layer DVD disc. Programsand data can be stored in layer 0 and/or layer 1 of this area of thedisc. In particular, inner data area 304 preferably encodes instructionsthat direct the optical disc reader to adjust its focus to the correctdata layer in order to read the analyte-specific signals disposed oninserts 506, 507, 508, and 509. Furthermore, inner data area 304 canstore data used to adjust the firmware or “flash” components of thedrive chipset, as may be needed by the drive to correctly read andinterpret analyte-specific signals.

Cover portion 303 and inserts 506, 507, 508, and 509 can include atranslucent optical material, such as polycarbonate, polymethyl acrylic,or glass. The material can be selected to optimize the detection of thesignal elements. Inserts 506, 507, 508, and 509, and cover portion 303can be configured such that the analyte-specific signal elements arephysically segregated from operational structures.

There are many variations that could be made based on the embodimentshown in FIG. 16. For example, if large amounts of data and/orprogramming are needed to interpret the results of an assay, inner dataarea 304 could have data written both on layer 0 and on layer 1, withoutaltering the data structure in the outer assay area 306.

FIG. 17 shows a side cross-sectional view of another multi-layerembodiment of an assay disc assembly built in accordance with thepresent invention. Disc assembly 320 includes one or more spaces orchambers 322. Assays may be performed by introducing into spaces 322,inserts 512 or 514. Investigational structures or analytes are placed onthe inserts. Layer 1 of disc assembly 320 is embossed with a wobblegroove in its laser-proximal surface, and provides at least the minimaloperational structures required by an optical disc reader to operate thedisc assembly. Layer 0 of disc 320 may contain data necessary for theoptical disc reader to detect the investigational structures orinterpret the detection results.

Multiple assays can be performed using a disc assembly having multipleseparate assay spaces, such as spaces 322. In addition, the location ofspaces 322 within the disc assembly can be varied. For example, spaces322 can be closer to either layer 0 or layer 1, or roughly at thehalfway point between layer 0 and layer 1. In either case, the analytedisposed within spaces 322 may be detected using a light beam which canbe focused on either the laser-proximal surface of layer 1 or thelaser-distal surface of layer 0.

FIG. 18 shows a side cross-sectional view of yet another multiple layerassay disc assembly. The assay disc assembly 330 is similar to discassembly 320 in FIG. 17. In the case of disc 330, spaces 332 are locatedtoward the outer portion of the assembly resulting in a central portion334 as a “standard” two layer disc. Inserts 516 and 518 can be sized tofit into spaces 332. Layer 0 of disc 330 is divided into two sections.Section 334 of Layer 0 can be used to store data and/or programs.Section 336 of layer 0 may include a translucent material having opticalproperties different from those of section 334. In a preferredembodiment, the optical properties of section 336 are optimized forfocusing a light beam onto the operational structures of the disc, orfor detecting the analyte disposed on inserts 516 and 518 that aredisposed in spaces 332. Disc 330 can be read by a DVD reader, but canalso be read by a CD reader such as a CD-R reader or preferably a CD-RWreader.

FIG. 19 shows a disc assembly 340. Data encoded in layer 0 can bearranged according to a DVD format and may be read by a standard DVDplayer. Data encoded in layer 1, which includes layer 344 and layer 342,can be in a CD-Recordable format. Layer 344 may be embossed withoperational structures. Spaces 346, which are adjacent to layer 344, arecapable of receiving inserts to perform assays.

FIG. 20 shows a two-layer disc 350. Data and operational structures inlayer 1 are provided by hologram 352. The operational structures anddata encoded in hologram 352 appear to reside in the hologram's imageplane 354. The image plane may be either laser distal or laser proximalrelative to hologram 352. In FIG. 20, the image plane 354 is laserproximal relative to the hologram 352. Inserts can be inserted intospaces 356. Analytes disposed on inserts 500 may be detectable using alight beam that is focused on the image plane 354.

A hologram similar to hologram 352 can be used to provide layer 1 innearly any of the multiple layer discs described above. Analytes may bedisposed directly on the surface of the hologram, or within or adjacentto the image plane of the hologram.

The foregoing embodiments for dual data layer discs can be easilyextended to use in discs which have more than two data or operationallayers. Spaces or channels that are used to receive inserts can belocated between any two data layers. Each of the layers may providerequired operational structures or encode data for conducting analyteassays. In one embodiment, the most laser-proximal data layer does notencode operational information.

An insert in a disc assembly of this invention may have any shape, suchas those shown in FIG. 21, including a substantially rectangular shape526 which may conform to the shape of a standard microscope slide. Thisshape can be used in both the disc assemblies of the present inventionand conventional microscopy. Other shapes may also be used. For example,the insert may have a substantially triangular shape 528 (includingpie-shaped), a semi-circular shape 530, a ring shape 532, or any othersuitable shapes. Substantially triangular inserts may minimizeinterference with the operational characteristics of the present system,and may maximize the orthogonality of insert edges and tracks.

Multiple ring-shaped inserts may be used, for example, to performmultiple assays on a single disc, as shown in FIG. 22. As shown in FIG.23, a single disc assembly 550 can be configured to accommodatedifferent shaped inserts 534, 535, 536, 538, and 540.

The weight of the insert may cause the disc assembly to spin in anunbalanced fashion. Thus, counterweights can be used to balance theweight of the disc. Covers or the optical discs themselves can bemanufactured, for example, with one or more section or attachment sites.FIG. 24 shows sites 556 and 558 can be diametrically positioned on theopposite sides in the disc assembly. Counterweight 554, whichapproximates the weight of the sample and insert 552, may be placed intosite 558 which is opposite to site 556 in which insert 552 ispositioned. The counterweights may be any suitable solid or fluid. Inone embodiment, the disc can be manufactured with an irregular portionthat is positioned opposite to the insertion or attachment site andweighted to compensate for the weight of the insert. If desired, acircumferential channel 562 can be used, as shown in FIG. 25. Annularchannel 562 can be filled with materials capable of traveling inside thechannel in order to balance the disc assembly against insert 564.

A method for using an optical disc assembly of the present invention isdescribed as follows. A technician can, for example, apply a sample offluid or tissue containing an analyte of interest to an insert. Afterapplying the sample, the insert is inserted or otherwise attached to adisc assembly at an appropriate site. Preferably, the disc assembly hasa cover. The disc assembly thus prepared is inserted into a CD or DVDreader, and the sample is assayed and analyzed, as described, forexample in U.S. patent application Ser. No. 09/378,878, entitled“Methods and Apparatus for Analyzing Operational and Nonoperational DataAcquired from Optical Discs”; U.S. Provisional Application Ser. No.60/270,095, filed Feb. 20, 2001, entitled “Signal Processing Apparatusand Methods For Obtaining Signal Signatures of Investigational FeaturesDetected on a Surface of an Optical disc Assembly”; and U.S. ProvisionalApplication Ser. No. 60/292,108, filed May 18, 2001, entitled “SignalProcessing Apparatus and Methods For Obtaining Signal Signatures ofInvestigational Features Detected on a Surface of an Optical discAssembly” all of which are incorporated herein by reference. Signalsthat are indicative of the presence of the analyte can be obtained fromthe CD or DVD reader, and further processed using circuitry connected tothe CD or DVD reader.

While preferred illustrative embodiments of the present invention aredescribed, it will be apparent to one skilled in the art that variouschanges and modifications can be made therein without departing from theinvention. The present invention contemplates all such changes andmodifications which fall within the true spirit and scope of theinvention. In addition, the reader's attention is directed to theprovisional applications from which the present application claimspriority. The contents of all these provisional applications areincorporated herein by reference.

1. An optical disc assembly, comprising: a cover portion comprising atleast one insert having a surface capable of receiving an analyte whichcan be detected by an optical disc reader; and a main portion comprisingan outer assay area, and an inner data area containing encodedinstructions that directs an optical disc reader to adjust its focus tothe correct data layer in order to read analyte-specific signal elementsdisposed on the at least one insert.
 2. The optical disc assembly ofclaim 1, wherein the optical disc reader is a DVD reader.
 3. The opticaldisc assembly of claim 1, wherein the inner data area further containsdata used to adjust the firmware or flash components of the optical discreader chipset so that the optical disc reader can correctly read andinterpret analyte-specific signals.
 4. The optical disc assembly ofclaim 1, wherein the outer assay area comprises at least one operationalstructure.
 5. The optical disc assembly of claim 4, wherein theoperational structure comprises a radial plane tracking feature toprovide tracking information to the optical disc reader.
 6. The opticaldisc assembly of claim 4, wherein the at least one operational structurecomprises a wobble groove.
 7. The optical disc assembly of claim 6,wherein the wobble groove comprises a forward image groove.
 8. Theoptical disc assembly of claim 6, wherein the wobble groove comprises areverse image groove.
 9. The optical disc assembly of claim 1, whereinthe inner data area comprises a first layer and a second layer, andwherein programs, instructions, or data can be stored in either thefirst layer or the second layer.
 10. The optical disc assembly of claim1, wherein the inner data area comprises a first layer and a secondlayer, and wherein programs, instructions, or data are stored in boththe first layer and the second layer.
 11. The optical disc assembly ofclaim 1, wherein the cover portion comprises a translucent opticalmaterial.
 12. The optical disc assembly of claim 11, wherein the opticalmaterial comprises polycarbonate, polymethyl acrylic, or glass.
 13. Theoptical disc assembly of claim 11, wherein the optical material affectsa light beam from the optical disc reader so as to optimize thedetection of the analyte-specific signal elements disposed on the atleast one insert.
 14. The optical disc assembly of claim 1, wherein theat least one insert comprises analyte-specific signal elements, andwherein the cover portion is configured such that the analyte-specificsignal elements are physically segregated from operational structures inthe cover portion or the main portion.
 15. The optical disc assembly ofclaim 1, wherein the cover portion and the main portion are permanentlyaffixed to each other.
 16. The optical disc assembly of claim 1, whereinthe cover portion and the main portion are affixed to each other suchthat they can be separated.
 17. The optical disc assembly of claim 1,wherein the at least one insert is inserted into the cover portion. 18.The optical disc assembly of claim 1, wherein the at least one insert isattached to the cover portion.
 19. The optical disc assembly of claim 1,wherein the cover portion is assembled over the outer assay area of themain portion.
 20. The optical disc assembly of claim 1, wherein theinner data area and a cutout portion of the cover portion are configuredso as to permit a snug coupling between the main portion and the coverportion.
 21. A method of detecting an analyte held by the optical discassembly of claim 1, comprising: providing the optical disc assembly tothe optical disc reader; reading the optical disc assembly; andobtaining a signal which is indicative of the presence of the analyte.22. A kit for detecting an analyte, comprising: an insert having asurface capable of receiving an analyte and analyte-specific signalelements which can be detected by an optical disc reader; and a disccomprising a cover portion capable of receiving the insert, and furthercomprising a main portion comprising an outer assay area and an innerdata area, the inner data area containing encoded instructions thatdirects an optical disc reader to adjust its focus to the correct datalayer to enable the optical disc reader to read the analyte-specificsignal elements disposed on the at least one insert.